21 USC 360bbb-8d - Notification, nondistribution, and recall of controlled substances

U.S Code last checked for updates: Nov 22, 2024

§ 360bbb–8d.

Notification, nondistribution, and recall of controlled substances

(a)

Order to cease distribution and recall

(1)

In general

(2)

Hearing

(3)

Order resolution

After an order is issued according to the process under paragraphs (1) and (2), the Secretary shall, except as provided in paragraph (4)—

(A)

vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;

(B)

continue the order ceasing distribution of the controlled substance until a date specified in such order; or

(C)

amend the order to require a recall of the controlled substance, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.

(4)

Risk assessment

(5)

Action following order

(b)

Notice to persons affected

(c)

Nondelegation

(d)

Savings clause

Nothing contained in this section shall be construed as limiting—

(1)

the authority of the Secretary to issue an order to cease distribution of, or to recall, any drug under any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.]; or

(2)

the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this chapter or the Public Health Service Act.

(June 25, 1938, ch. 675, § 569D, as added Pub. L. 115–271, title III, § 3012(b), Oct. 24, 2018, 132 Stat. 3935.)

cite as: 21 USC 360bbb-8d